YBB 6006-2012 English PDF (YBB6006-2012)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get QUOTATION in 1-minute: Click YBB 6006-2012
Historical versions: YBB 6006-2012
Preview True-PDF (Reload/Scroll if blank)

YBB 6006-2012: The Test Method for Residue of Solvent in Packaging Material
YBB6006-2012
State Food and Drug Administration
of the People’s Republic of China
Direct contact with drug’s
packaging materials and containers standard
National Institutes for Food and Drug Control
Packaging Materials and Pharmaceutical Excipients Inspection Institute
December 2012
The Test Method for Residue
of Solvent in Packaging Material
This method applies to the determination of residual solvents in pharmaceutical packaging
materials.
This method is based on the gas - solid balance. Take a certain area of the sample. Place into a
sealed container. Under a certain temperature and time conditions, the organic solvent resided
in the sample is heated and evaporated. After the equilibrium is reached, take headspace to
quantitative inject into the gas chromatograph for analysis. Use the maintaining time to perform
qualification. Use the peak area to perform quantitation. Determine according to the
determination of residual organic solvents (Appendix Ⅷ P, Part 2, Chinese Pharmacopoeia 2010
edition).
Chromatographic conditions and system suitability test
Capillary column or other suitable columns that can satisfy the requirements of the test solvent
separation may be selected.
Use the chromatographic-peak of the test substance to calculate. The number of theoretical
plates is generally not less than 1000.
Unless otherwise specified, the same-type capillary columns with similar polarity can substitute
each other. Number of theoretical plates: It must not be less than 5000.
1. Non-polar column: 100% dimethylpolysiloxane.
2. Polar column: Polyethylene glycol PEG-20M.
3. Medium-polar column: 6% cyanopropyl phenyl-94% dimethylpolysiloxane.
4. Low-polar column: 5% phenyl-95% methyl polysiloxane.
General selection:
Column: INNOWAX 0.32mm × 0.5μm × 60m
Detector: Flame ionization detector (FID)
Measurement conditions (for reference): Column temperature: Initial temperature is 50 °C.
Maintain for 5 minutes. Then rise the temperature at a rate of 10 °C per minute TO 150 °C. Inlet
temperature is 200 °C. The detector temperature is 220 °C.
Split ratio: 10: 1
Nitrogen 2 ml / min; hydrogen 30ml / min; air 400ml / min
Separation: The separation BETWEEN the chromatographic-peak of the test substance AND its
adjacent chromatographic-peak shall be greater than 1.5.
The relative standard deviation of the test substance’s peak area shall not exceed 10%.